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Liraglutide as add-on to Insulin in Type 1 Diabetes (T1DMLIRA)

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ClinicalTrials.gov Identifier: NCT02092896
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
NNF Center for Basal Metabolic Research, Denmark
Hillerod Hospital, Denmark
Danish PhD schools of Molecular Metabolism and Endocrinology
Novo Nordisk A/S
Information provided by (Responsible Party):
Christan SS Frandsen, MD, Hvidovre University Hospital

Study Description
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Brief Summary:

The purpose of this study is to:

Part 1:

To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

Part 2:

To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Liraglutide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
Study Start Date : March 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo + Insulin + Study 2
Study 2: Cognitive performance test
 Drug: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Experimental: Liraglutide + Insulin + Study 2
Study 2: Cognitive performance test
 Drug: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Experimental: Liraglutide + Insulin + Study 1
Study 1: Gastric emptying test
 Drug: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Placebo Comparator: Placebo + Insulin + Study 1
Study 1: Gastric emptying test
 Drug: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 12 ]
  2. Changes from baseline in EEG and cognitive performances [ Time Frame: week 0, week 12 ]
  3. Change from baseline in gastric emptying rate [ Time Frame: week 0, week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in glycemic control (CGM) [ Time Frame: week 0, week 12 ]
  2. Change from baseline in total daily insulin dose [ Time Frame: week 0, week 12 ]
  3. Changes from baseline in the counterregulatory hormone responses during hypoglycemia [ Time Frame: week 0, week 12 ]
  4. Change from baseline in body weight [ Time Frame: week 0, week 12 ]
  5. Change from baseline in auditory evoked potentials (AEP) during hypoglycemia [ Time Frame: week 0, week 12 ]
  6. Change from baseline in corrected QTc-interval (QTc) during hypoglycemia [ Time Frame: week 0, week 12 ]
  7. Change from baseline in hypoglycemic symptom score [ Time Frame: week 0, week 12 ]

Other Outcome Measures:
  1. Frequency of Hypoglycemic episodes [ Time Frame: Week 0, week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-70 years
  • BMI: 18-28
  • HbA1c ≥ 8 %
  • No residual β-cell function (glucagon test with c-peptide < 60 pM)
  • Caucasian
  • Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
  • Remission phase must be completed
  • Female participants must use adequate contraception
  • Informed consent

Exclusion Criteria:

  • Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
  • Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
  • Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
  • Pregnancy or lactation
  • Epilepsy
  • Use of antiepileptic medication
  • Use of beta blockers
  • Previously apoplexy cerebri.
  • Any use of benzodiazepine within the last month
  • Any use of neuroleptic drugs within the last six months
  • Self-perceived hearing loss
  • Alcohol or drug abuse
  • Allergy to the medication or placebo.
  • Treatment with any medication affecting glucose metabolism.
  • Any disorder which in the investigators opinion could interfere with the safety and results of the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092896


Locations
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Denmark
Dept. of Endocrinology, Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
NNF Center for Basal Metabolic Research, Denmark
Hillerod Hospital, Denmark
Danish PhD schools of Molecular Metabolism and Endocrinology
Novo Nordisk A/S
Investigators
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Principal Investigator: Christian SS Frandsen, MD Hvidovre University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christan SS Frandsen, MD, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02092896    
Other Study ID Numbers: 2012-002526-67
2012-002526-67 ( EudraCT Number )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Christan SS Frandsen, MD, Hvidovre University Hospital:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Cognitive performance
Hypoglycemia
Insulin
 Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists